Remote Clinical Research Associate – Global Site Monitoring

Syneos Health, Inc.; Providence (RI); Presencial; USD 90.000 - 120.000; Jornada completa

Descripción de la vacante

Syneos Health is seeking an Experienced Clinical Research Associate regionally aligned across the US. The role focuses on site qualification, initiation, monitoring, and close-out with strict adherence to ICH-GCP, regulatory requirements and CMP/SMP guidelines.

You will verify informed consent, manage data integrity, conduct source data reviews and support IP inventory and site management activities. Travel up to 75% is required.

Formación

• Bachelor's degree or RN in a related field.
• Knowledge of GCP/ICH guidelines and regulatory requirements.
• Strong computer skills and ability to adopt new technologies.
• Excellent communication, presentation and interpersonal skills.
• Willingness to travel up to 75% regularly.

Responsabilidades

• Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (on-site or remote) ensuring regulatory, ICH-GCP and/or GPP and protocol compliance.
• Verifies informed consent processes and protects confidentiality, assessing factors affecting subject safety and data integrity.
• Per the CMP/SMP: assesses site processes, conducts source data review, ensures CRF accuracy, drives query resolution, and supports data capture.
• May perform IP inventory, reconciliation and reviews storage and security; ensures IP is labelled/released per protocol.
• Reconciles ISF with TMF and ensures archiving of essential documents per guidelines.
• Documents activities via letters, logs and reports; supports recruitment and data tracking.
• Manages site-level activities, timelines and budgets; adapts to changing priorities to meet goals.
• Acts as liaison with site personnel; ensures training and compliance of site team members.
• Prepares for Investigator Meetings and sponsor meetings; participates in global trials as applicable.
• Provides guidance toward audit readiness and supports required follow-up actions.
• Maintains knowledge of ICH/GCP and company SOPs; may include site support through the study lifecycle.
• Additional responsibilities include training junior staff and identifying out-of-scope activities.

Conocimientos

Communication skills

Interpersonal skills

GCP/ICH knowledge

Computer skills

Travel willingness

Presentation skills

Educación

Bachelor's degree or RN in a related field

Descripción del empleo

Syneos Health is seeking an Experienced Clinical Research Associate regionally aligned across the US. The role focuses on site qualification, initiation, monitoring, and close-out with strict adherence to ICH-GCP, regulatory requirements and CMP/SMP guidelines.

You will verify informed consent, manage data integrity, conduct source data reviews and support IP inventory and site management activities. Travel up to 75% is required.